Chemotherapy +/− Ramucirumab for Thymic Cancer

Recruiting at 253 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: SWOG Cancer Research Network

Must not be taking: Antiplatelets, NSAIDs

Disqualifiers: Hypertension, Thromboembolism, Cirrhosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 9

Duration: 18 weeks

21 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing whether adding ramucirumab to standard chemotherapy helps treat advanced thymic cancer better than chemotherapy alone. It targets patients whose cancer has spread, returned, or can't be surgically removed. The chemotherapy drugs kill or stop the growth of cancer cells, while ramucirumab blocks tumor growth signals. Ramucirumab has shown positive results in combination with paclitaxel for advanced gastric cancer.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on warfarin, you must switch to low molecular weight heparin 14 days before joining the trial. Also, you should not be on chronic antiplatelet therapy, like certain NSAIDs, within 7 days before starting the trial.

What data supports the effectiveness of the drug combination of chemotherapy and Ramucirumab for thymic cancer?

Research shows that the combination of paclitaxel and carboplatin, which are part of the chemotherapy drugs being studied, has been effective in treating advanced thymic carcinoma, with a response rate of up to 50% in some studies. This suggests that these drugs can help control the disease in a significant number of patients. ^{1 2 3 4 5}

Is the combination of chemotherapy drugs, including paclitaxel and carboplatin, safe for treating thymic cancer?

The combination of paclitaxel and carboplatin has been generally well-tolerated in patients with advanced thymic cancer. Common side effects include mild to moderate nausea, anemia (low red blood cell count), and hair loss, with no severe toxicities or treatment-related deaths reported in the studies. ^{1 2 3 6 7}

How does the drug combination of Carboplatin and Paclitaxel differ from other treatments for thymic cancer?

The combination of Carboplatin and Paclitaxel is unique for thymic cancer as it is used as a first-line treatment and has shown good efficacy and safety, with a 50% response rate in advanced cases, despite there being no established optimal chemotherapy regimen for this rare cancer. ^{1 3 4 8 9}

Research Team

Anne S Tsao

Principal Investigator

SWOG Cancer Research Network

Eligibility Criteria

This trial is for adults with advanced, recurrent, or metastatic thymic cancer that can't be surgically removed. They should not have had previous systemic anti-cancer therapy for this condition and must have measurable disease. Participants need proper liver and kidney function, no significant blood clots or bleeding in recent months, controlled blood pressure, and cannot be pregnant or breastfeeding.

Inclusion Criteria

My thymic carcinoma cannot be removed by surgery and has spread.

I haven't had major surgery in the last 28 days or minor surgery in the last 7 days.

My cancer can be seen on scans taken within the last 28 days.

Exclusion Criteria

I do not have any disqualifying conditions.

My liver disease is severe (Child-Pugh B or worse).

I have liver cirrhosis and a history of brain issues due to it.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive carboplatin and paclitaxel with or without ramucirumab every 21 days for up to 6 cycles

18 weeks

6 visits (in-person)

Extension

Patients who have not progressed may continue to receive ramucirumab for up to 1 year

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Every 3 months for 1 year, then every 6 months for 1 year

Treatment Details

Interventions

• Carboplatin
• Paclitaxel
• Ramucirumab

Trial Overview The study compares the effectiveness of chemotherapy drugs carboplatin and paclitaxel alone versus combined with ramucirumab (a monoclonal antibody) in treating thymic cancer. The goal is to see if adding ramucirumab improves treatment outcomes compared to just chemotherapy.

Participant Groups

Group I: Arm A (ramucirumab, carboplatin, paclitaxel) Experimental Treatment 3 Interventions

Patients receive ramucirumab IV over 60 minutes, carboplatin IV, and paclitaxel IV on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients who have not progressed may continue to receive ramucirumab for up to 1 year.

Group II: Arm B (carboplatin, paclitaxel) Active Control 2 Interventions

Patients receive carboplatin IV and paclitaxel IV on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

Carboplatin is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Paraplatin for:

• Ovarian cancer
• Testicular cancer
• Lung cancer
• Head and neck cancer
• Brain cancer

Approved in European Union as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer

Approved in Canada as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer
• Testicular cancer

Who Is Running the Clinical Trial?

SWOG Cancer Research Network

Lead Sponsor

Trials

403

Recruited

267,000+

Southwest Oncology Group

Lead Sponsor

Trials

389

Recruited

260,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

A multicenter phase II study is investigating the combination of atezolizumab (an anti-PD-L1 antibody) with carboplatin and paclitaxel in 47 patients with advanced or recurrent thymic carcinoma, aiming to improve treatment outcomes compared to standard chemotherapy.

The study will assess the safety and efficacy of this combination therapy, with the primary focus on the objective response rate, and will follow patients for up to 2 years to evaluate long-term effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study Design and Rationale for Marble Study: A Phase II Trial of Atezolizumab (MPDL3280A) Plus Carboplatin and Paclitaxel in Patients With Advanced or Recurrent Thymic Carcinoma (JTD2101). Asao, T., Shukuya, T., Mimori, T., et al.[2023]

In three cases of unresectable and locally advanced thymic carcinoma resistant to cisplatin, treatment with carboplatin and paclitaxel as salvage chemotherapy resulted in two patients showing a partial response and one showing a minor response.

The findings suggest that thymic carcinoma is sensitive to platinum-based chemotherapy, and paclitaxel may also be an effective treatment option for this type of cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Salvage chemotherapy with carboplatin and paclitaxel for cisplatin-resistant thymic carcinoma--three cases. Komatsu, Y., Koizumi, T., Tanabe, T., et al.[2015]

References

1. Singapore pubmed.ncbi.nlm.nih.gov

Efficacy and safety of the combination of paclitaxel and platinum in advanced thymic carcinoma. [2018]

2. China pubmed.ncbi.nlm.nih.gov

Chemotherapy with paclitaxel plus carboplatin for relapsed advanced thymic carcinoma. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Combination carboplatin and nab-paclitaxel as a first-line treatment for advanced thymic carcinoma. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Study Design and Rationale for Marble Study: A Phase II Trial of Atezolizumab (MPDL3280A) Plus Carboplatin and Paclitaxel in Patients With Advanced or Recurrent Thymic Carcinoma (JTD2101). [2023]

5. Greece pubmed.ncbi.nlm.nih.gov

Paclitaxel and cisplatin with concurrent radiotherapy followed by surgery in locally advanced thymic carcinoma. [2015]

6. England pubmed.ncbi.nlm.nih.gov

Carboplatin plus nanoparticle albumin-bound paclitaxel for the treatment of thymic carcinoma. [2022]

7. Japan pubmed.ncbi.nlm.nih.gov

[A case of thymic cancer effectively treated by weekly paclitaxel combined with carboplatin]. [2015]

8. Greece pubmed.ncbi.nlm.nih.gov

Salvage chemotherapy with carboplatin and paclitaxel for cisplatin-resistant thymic carcinoma--three cases. [2015]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Cisplatin and Irinotecan as First-Line Chemotherapy for Previously Untreated Metastatic Thymic Carcinoma: Updated Analysis. [2022]